Status:
COMPLETED
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Resectable Pancreatic Adenocarcinoma
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief Summary
This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical...
Detailed Description
Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT) with low energy...
Eligibility Criteria
Inclusion
- 1\. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable the following criteria must be met:
- Absence of distant metastases
- Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
- Absence of direct involvement of inferior vena cava or aorta
- Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows:
- Hemoglobin \>10 g/dL, Absolute Neutrophil Count (ANC) \>1,500/mm3, Platelets \>100,000/mm3
- Serum Cr \<1.4 mg/dL, BUN \<20 mg/dL 6. Ability to understand and the willingness to sign a written informed consent
Exclusion
- 1\. Patients who have received external beam radiotherapy in the abdominal area 2. Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. Patients who have received neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6. Current pregnancy or currently nursing
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03273374
Start Date
August 14 2017
End Date
August 22 2022
Last Update
September 13 2023
Active Locations (1)
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1
Gangnam Severance Hospital
Seoul, South Korea